BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 16387550 · Received February 16, 2023

    Report

    Report Number
    0001825034-2023-00341
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 25, 2023
    Report Date
    April 13, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)- HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY WITH IMPLANT DISSOCIATION AT THE JUNCTION OF THE FEMORAL HEAD AND NECK A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: X11-180313, ITEM NAME: BI-METRIC/X POR NC LAT 13X145M LOT NUMBER: 386650; ITEM NUMBER: 15-106056, ITEM NAME: M2A-38 CUP NON FLARED SZ 56MM, LOT NUMBER: 949000; ITEM NUMBER: 31-323230, ITEM NAME: 3.2MMX30MM RNGLC+ ACET DRL BIT, LOT NUMBER:355010; ITEM NUMBER: 00-510-400-00, ITEM NAME: EXODUS HIP STEM REMOVAL BLADES, LOT NUMBER: 21021; ITEM NUMBER: 430060, ITEM NAME: RADIAL OSTEOTOME 6MM, LOT NUMBER: 541312; ITEM NUMBER: 11-300818, ITEM NAME: ARCOS 18X150MM SPL TPR DIST, LOT NUMBER: 381820; ITEM NUMBER: 11-301312, ITEM NAME: ARCOS CON SZ B HI 60MM, LOT NUMBER: 838120; ITEM NUMBER: 11-302101, ITEM NAME: ARCOS TROCH CLAW LARGE 100MM, LOT NUMBER: 506530; ITEM NUMBER: 11-302138 ITEM NAME: ARCOS LATERAL TROCH BOLT 38MM, LOT NUMBER:240720; ITEM NUMBER: 650-1055, ITEM NAME: CER BIOLOXD OPTION HD 28MM, LOT NUMBER: 3130999; ITEM NUMBER: 650-1064, ITEM NAME: CER OPTION TYPE 1 TPR SLEVE -6, LOT NUMBER: 3100122; ITEM NUMBER: 110010268, ITEM NAME: G7 OSSEOTI MULTIHOLE 60MM G, LOT NUMBER: 6833750; ITEM NUMBER: 110024465, ITEM NAME: G7 DUAL MOBILITY LINER 46MM G, LOT NUMBER: 358140; ITEM NUMBER: 110031013, ITEM NAME: VIVACIT-E DM BEARING 28X46MM, LOT NUMBER: 65254751; ITEM NUMBER: 00-6250-065-40, ITEM NAME: BONE SCREW 6.5X40 SELFTAP, LOT NUMBER: J7250390; ITEM NUMBER: 00-6250-065-25, ITEM NAME: BONE SCREW 6.5X25 SELFTAP, LOT NUMBER: J7280773; ITEM NUMBER: 00-6250-065-30, ITEM NAME: BONE SCREW 6.5X30 SELFTAP LOT NUMBER: 65514448; ITEM NUMBER: 65514448, ITEM NAME: BONE SCREW 6.5X30 SELFTAP, LOT NUMBER: 65013422; ITEM NUMBER: 00-2232-004-18, ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM, LOT NUMBER: 65459439; ITEM NUMBER: 00-2232-004-18, ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM, LOT NUMBER: 65632345; ITEM NUMBER:00-2232-004-18, ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM, LOT NUMBER: 65656496. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00342 AND 0001825034 - 2023 - 00339 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A DISLOCATED HIP AND DISASSOCIATED FEMORAL HEAD FROM STEM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608825 M2A 38MM MOD HD +3MM NK PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 780870

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H